PMA · Approved
Recalled · Class II · 2016Radiesse Injectable Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merz North America, Inc. · LMH Implant, Dermal, For Aesthetic Use
Approved on Dec 22, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 365-day review. It has been recalled 3 times.
- Decided
- Dec 22, 2006
- Review
- 365 days
- Class
- Class III
- Product code
- LMH
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050052 has 169 supplements since 2007: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2007 | 2 |
| 2008 | 11 |
| 2009 | 7 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 8 |
| 2013 | 10 |
| 2014 | 10 |
| 2015 | 17 |
| 2016 | 13 |
| 2017 | 11 |
| 2018 | 8 |
| 2019 | 7 |
| 2020 | 10 |
| 2021 | 5 |
| 2022 | 6 |
| 2023 | 13 |
| 2024 | 12 |
| 2025 | 7 |
| 2026 | 7 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2016 | Class II | Z-2607-2016 | Nonconforming Material/Component | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. |
| Aug 18, 2011 | Not classified | Z-0145-2012 | Nonconforming Material/Component | There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the… |
| Apr 6, 2011 | Not classified | Z-2221-2011 | Employee error | Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LMH devicesLMH Implant, Dermal, For Aesthetic Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMH
51in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LMH
Too few LMH 510(k)s in any year since 2007 to give a median.
Recalls per year · LMH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMH
1,805in 2025
MAUDE reports naming product code LMH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | — | 0 | 175 |
| 2008 | 50 | — | 0 | 308 |
| 2009 | 37 | — | 0 | 1,217 |
| 2010 | 19 | — | 0 | 736 |
| 2011 | 21 | — | 2 | 449 |
| 2012 | 44 | — | 0 | 402 |
| 2013 | 39 | — | 0 | 451 |
| 2014 | 61 | — | 0 | 786 |
| 2015 | 60 | — | 1 | 885 |
| 2016 | 45 | — | 0 | 691 |
| 2017 | 52 | — | 0 | 1,509 |
| 2018 | 57 | — | 0 | 1,803 |
| 2019 | 68 | — | 0 | 1,273 |
| 2020 | 61 | — | 0 | 1,156 |
| 2021 | 51 | — | 0 | 1,422 |
| 2022 | 40 | — | 0 | 1,358 |
| 2023 | 81 | — | 0 | 1,478 |
| 2024 | 74 | — | 0 | 1,372 |
| 2025 | 51 | — | 0 | 1,805 |
| 2026 | 56 | — | 0 | — |
https://510kreport.com/device/P050052 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050052: Radiesse Injectable Implant.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050052
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026